Focal salvage brachytherapy for recurrent prostate cancer
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
This study is testing a targeted radiation treatment for men with recurring prostate cancer after previous radiation to see if it can help them without harming nearby organs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Greater Poland Cancer Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Poznan, Greater Poland Voivodeship) |
| Trial ID | NCT05715502 on ClinicalTrials.gov |
What this trial studies
This prospective phase II study evaluates the safety and toxicity of focal salvage brachytherapy in patients with localized recurrence of prostate cancer after prior radiotherapy. The study aims to treat patients who have experienced local recurrence while ensuring that critical organs are protected from excessive radiation exposure. Patients will undergo imaging assessments to confirm localized tumors and exclude distant metastases before receiving the brachytherapy treatment. The goal is to provide a targeted approach that may improve outcomes for patients with recurrent prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed localized recurrence of prostate cancer after prior radical radiotherapy and specific PSA levels.
Not a fit: Patients with distant metastases, high PSA levels, or significant comorbidities may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could offer a less toxic and more effective option for patients with recurrent prostate cancer.
How similar studies have performed: Previous studies have shown promise for salvage brachytherapy in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy) * Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT * Exclusion of distant metastases using CT, MR, or PET imaging * PSA doubling time over six months * PSA value \<10 ng / ml * No anti-androgen treatment in the year prior * Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points * General condition according to the WHO scale ≤ 2 * Signing informed consent to participate in the study Exclusion Criteria: * PSA value\> 10ng / ml * General condition according to the WHO scale\> 2 * Dysuria on the IPSS scale\> 20 points * PSA doubling time \<6 months * Inability to discontinue anticoagulants. * An active urinary tract infection. * Contraindications to general anesthesia * Active inflammatory bowel diseases. * Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer * Estimated Survival \<5 years
Where this trial is running
Poznan, Greater Poland Voivodeship
- Greater Poland Cancer Centre / Brachytherapy Department — Poznan, Greater Poland Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Wojciech Burchardt, PhD, MD — Greater Poland Cancer Centre / Brachytherapy Department
- Study coordinator: Wojciech Burchardt, PhD, MD
- Email: wojciech.burchardt@wco.pl
- Phone: +48505149659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.